Technical Regulatory Affairs Expert

3 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $100,000 - $140,000
Senior Specialist Regulatory Affairs Job Description

About the Role

The Senior Specialist Regulatory Affairs will be responsible for leading regulatory strategy and execution for ResMed's core portfolio of devices. This includes authoring and reviewing global regulatory submissions, interpreting device-specific requirements, and aligning closely with Regional RA to ensure reusable, scalable submission approaches.

Key Responsibilities:

  • Author and review global regulatory submissions including FDA 510(k), CE MDR, TGA ARTG, and Health Canada dossiers for masks, CPAP devices, and ventilators.
  • Interpret device-specific requirements (e.g., ISO 17510, ISO 80601) and translate them into clear, well-supported regulatory documentation.
  • Align closely with Regional RA to ensure reusable, scalable submission approaches and consistent technical content.

Regulatory Strategy & Execution:

As a Senior Specialist in Regulatory Affairs, you will lead submission planning and execution, influence design documentation, and contribute to regulatory strategy for ResMed's core portfolio of devices.

Product Change & Lifecycle Support:

You will lead regulatory assessments of design and process changes, performing significance evaluations and preparing documentation updates. You will also provide regulatory input on system-level verification, biocompatibility, human factors, and labelling updates for high-volume products.

Cross-Functional Integration & Design Control Support:

You will represent RA in cross-functional design teams for products under Sydney legal manufacturer scope. You will engage early in project scoping and risk management activities to shape regulatory deliverables and timelines.

Mentorship & Peer Enablement:

You will mentor junior team members in regulatory interpretation, submission content quality, and cross-functional collaboration. You will support onboarding and documentation standardization across the Sydney RPSD team.

Required Skills and Qualifications:

  • Bachelor's degree in biomedical engineering, regulatory affairs, life sciences, or related discipline.
  • 5+ years of experience in Regulatory Affairs within a regulated industry (preferably medical devices).
  • Proven experience leading or coordinating global regulatory submissions (e.g., 510(k), CE Marking, TGA ARTG).
  • Strong knowledge of ISO 13485, ISO 14971, design control frameworks, and relevant market-specific regulations.
  • Excellent communication, project planning, and cross-functional influence skills.

Benefits:

This role offers the opportunity to work in a dynamic and structured environment, apply high analytical rigor, and consistently deliver compliant, high-quality documentation. You will bring people with you, clarify the complex, and help ResMed meet regulatory obligations while getting innovation to market faster.

Who We Are Looking For:

We are looking for a technical translator and regulatory mentor who thrives in structured environments, applies high analytical rigor, and consistently delivers compliant, high-quality documentation. You must have excellent communication, project planning, and cross-functional influence skills.

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